Clinical specimen-collecting austrument

ABSTRACT

An elongate clinical instrument comprises a blade and handle for collecting cells and tissues from body cavities, particularly for the detection of squamous carcinoma of the cervix. Two slanted spaced-apart edges on the blade tip describe a conical path during manual rotation in situ and gather specimens in troughs adjoining the edges. The blade tip is manually separable from the handle for forwarding to a pathology laboratory.

United States Patent 3,477,481 11/1969 Czerniewicz 145/116 X 2,505,358 4/1950 Gusberg et al 128/2 B 2,945,490 7/1960 Westcott 145/1 16 X 3,554,185 1/1971 Kohl 128/2 R 3,485,236 12/1969 Frost 128/2 B 786,358 4/1905 Houghton 128/253 741,886 10/1903 Chandler 206/634 FOREIGN PATENTS 820,527 8/1937 France 145/123 1,451,726 7/1966 France 128/2 B 1,173,267 12/1969 Great Britain..... 128/2 B 1,084,640 9/1967 Great Britain 128/2 B Primary Examiner-Aldrich F. Medbery Attorney-Edward H. Loveman ABSTRACT: An elongate clinical instrument comprises a blade and handle for collecting cells and tissues from body cavities, particularly for the detection of squamous carcinoma of the cervix. Two slanted spaced-apart edges on the blade tip describe a conical path during manual rotation in situ and gather specimens in troughs adjoining the edges. The blade tip is manually separable from the handle for forwarding to a pathology laboratory.

PATENTEU JAN! 7 I972 3.833.565

III

*1 I "I" "I Hank lnm ml BERNARD N? mNALD BACKGROUND OF THE INVENTION Devices commonly used for collection of samples as required for detection of interuterine cancer or the like typically include simple swabs, small wood sticks, brushes, or else relatively elaborate and costly aspirators. Since the cancer cells are fragile and break or fall away easily from any surface supporting them, and since surrounding tissues usually obscure the test area, it is often difficult to know whether such cells which might have been initially resting on a swab or stick were jarred or rubbed off and lost in the attempt to remove the same from the test situs.

The problems associated with specimen collecting in the foregoing context are notably difficult in the case ofsquamous carcinoma which most commonly originates at the squamo columnar junction. An accurate determination of cancer requires a complete survey of the entire test area, which would involve multiple biopsies, and even these would represent 10- calized portions rather than a comprehensive sampling of the total area. Ideally, fragments of tissue must be recovered representing the total test situs to permit preparation of histological slides which retain tissue architecture as opposed to cytology slides which present a collection of isolated cells. Surfaces which merely contact a tissue of a swab or stick collect only loose particles and not tissue fragments. Moreover, many doctors lack the time and patience to transfer every collected cell and particle from a stick onto a microscopic slide, whereby valuable diagnostic material may be lost, resulting in a risk or erroneous conclusion in respect of the patients condition.

Due to the foregoing limitations, many Pap Smears cannot be accurately diagnosed or else render only an ambiguous result. Where this is the case, a surgical procedure called cold conization is typically resorted to. However, this is a relatively major operation requiring hospitalization and general anesthesia. The invention device disclosed herein is designated to bridge this diagnostic gap between the office Pap Smear and the hospital cold cone thereby preserving many women from the risk of nondetection on one hand or the discomfort, danger, and expense inherent in a major operation.

SUMMARY OF THE INVENTION The invention in this case consists of an elongate tool or implement 10 for clinical or office use by physicians, and comprising a handle portion 12 and a blade portion 14. Blade portion 14 is essentially flat or planar and has a pair of oppositely facing and spaced-apart edges 16 and 18 adapted to scrape the entire circumference of the squamo columnar junction area with a deep-ploughing actionv A storing groove or trough 20 and 22 adjoins each of the edges 16 and 18, respectively, and receives the samplings progressively obtained by the stated edges during rotation of the instrument. Rotation is accomplished by force manually applied to handle portion 12. Following removal ofimplement 10 from the cervical canal, force is manually applied to portions 12 and 14 as required to break the implement at the location of thinned neck portion 17 therebetween, after which blade 14 with the collected matter in grooves 20 and 22 may be dropped into a biopsy bottle and sent to a laboratory for pathological analysis.

BRIEF DESCRIPTION OF THE DRAWING taken along line -5 of FIG. 6 shows a cross-sectional view taken along line 66 of FIG. 1.

DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIG. 1, implement 10 may be seen to comprise handle portion 12 and flat blade portion 14 integrally formed therewith of substantially rigid material such as plastic. Blade portion 14 has oppositely facing substantially parallel surfaces 13 and 15 seen particularly from FIG. 2, and a structurally weakened neck portion 17 defined by a transverse groove across both surfaces 13 and 15 resulting in a reduced crosssectional thickness as shown more clearly in FIG. 5.

Blade portion 14 is an elongate cutter shaped along the sides thereof to correspond generally with the natural contours of the cervix ofa human uterus as required for maximum effectiveness in performing its intended function. Thus, the opposite side contours defined by thin lips or cutting edges 16 and 18 may be seen to diverge from relatively close proximity therebetween near distal end 19 to a maximum width at oppositely directed projections 21 and 23. The edges 16 and 18 thus describe a conical path when implement 10 is rotated by manual force applied to handle 12. If only one edge were made to function as a specimen collector, the lateral forces on such blade would be unbalanced during rotation of implement 10 and its longitudinal axis in the manner described below, whereby two oppositely directed edges are preferred in the symmetrical relationship suggested by edges 16 and 18. A separate recessed groove adjoins each of the edges 16 and 18 as suggested by grooves 20 22, respectively, and extends coterminally therewith so as to describe the same conical path as edges 16 and 18 during rotation of implement 10 as discussed abovev The number of edges l6, 18 of adjoining grooves 20, 22 could be more than two in number, but as a practical matter only two of each, as suggested by the structure shown in the accompanying drawing, have been found to provide all the advantages sought in this case. Also, while the angularity of the edges 16, 18 and adjoining grooves 20, 22 could be varied slightly, the preferred arrangement is for the included angle to be from about 10 to 30 between the edges in that portion between distal end 19 and line 44 in FIG. 1, for example, increasing to about 45 to 60 included angle in the flared portion from line 4-4 to oppositely extending projections 21 and 23. Of particular importance is the fact that edges 16, 18 are directed in opposite directions as seen in FIGS. 3 and 4.

Distal end 19 of implement 10 has a bulbous or mushroomshaped protuberance extending therefrom and comprising button or dome 25 connected to end 19 by recessed shaft 26 of lesser diameter than portion 25. Dome 25 has a peripheral scraping edge 30 thereon. Handle portion 12 may be cylindrical, but in the preferred embodiment has a plurality of longitudinal strengthening ribs 27 symmetrically arranged about the center axis 28 of the handle as seen particularly from FIG. 6.

In operation, implement 10 is initially introduced onto the cervical canal with distal end 19 projecting therewithin and with oppositely directed projections 21 and 23 bearing against the outer surfaces of the squamo columnar junction. While thus positioned, implement 10 is rotated 360 about axis 28, although such rotation could obviously be more than one complete turn. During the foregoing movement, edges 16 and 18 bear uniformly throughout their length with the surfaces which they contact and which have substantially the same contours as the path defined by the edges during the stated rotation. The relationship between edges 16, 18 and grooves 20, 22 as discussed above results in a plowing and scraping action whereby edges 16, 18 detach cells, surface tissue and other diagnostic material from the test situs, such material being channeled into the mentioned grooves as it is progressively accumulated. During withdrawal ofimplement l0, additional cells or the like are captured by the mild scraping action of the peripheral edge 30 of protuberance 25 and retained about recessed shaft portion 26 on distal end 19 of the implement. Thereafter, force is applied through portions 12 and 14 as required to fracture completely through groove 17 and separate the two stated portions. Blade portion 14, with the collected matter in grooves 20, 22 is then dropped into a biopsy bottle which is sealed and sent to a laboratory for pathological analysis.

From the foregoing, it may be seen that the structure and method in this case provide a rapid and effective means for collecting diagnostic matter and with a minimum of specialized skill. The plowing and scraping action of blade edges l6, l8 assures complete collection of matter throughout the entire test area whereby a comprehensive sampling is achieved, and further assures that such matter will include surface tissue structure rather than loose cells only. The area thus sampled is wider and of greater yield potential than could be accomplished by multiple biopsies. The tissue sheared from the test surface is shallow, so that pain or postoperative bleeding are not encountered in using implement 10. Moreover, the procedure can be carried out simply during the course of a pelvic examination in a medical office and requires no elaborate medical or hospital surgery equipment.

I claim: 1. An elongate substantially rigid implement for collecting diagnostic material in situs from body cavities, comprising:

handle means at one end of said implement for manually rotating said implement about a rotational axis through the longitudinal center of said elongate implement,

projection means extending radially from said handle means adjacent to and axially spaced from the distal end of said handle means,

blade means secured to said handle means,

said blade means including at least two spaced-apart slanted cutting edges, relative to said rotational axis, and which extend from said distal end of said implement and include the upper portions of said projection means and which describe a conical path during rotation of said implement, the lower portions of said projection means constituting a noncutting portion,

each of said blade means further including a recessed groove adjoining said cutting edge and extending along the length thereof for receiving said diagnostic material collected by said edge from said situsv 2. The structure set forth in claim 1 above, further includmg:

a structurally weakened neck portion between said handle means and said blade means for breaking the same apart by application of manual force thereto.

3. The structure set forth in claim 1 above, wherein:

said elongate implement further includes at said distal end a domelike protuberance having means to scrape over said situs when said implement is removed therefrom.

4. The structure set forth in claim 2 above wherein said elongate implement further includes a domelike protuberance and a reduced cylindrical portion fixed to said distal end, said protuberance having a peripheral edge thereon for scraping over said situs when said implement is removed therefrom.

5. The structure set forth in claim 2 above wherein said blade means comprises at least two oppositely facing substantially parallel surfaces. 

1. An elongate substantially rigid implement for collecting diagnostic material in situs from body cavities, comprising: handle means at one end of said implement for manually rotating said implement about a rotational axis through the longitudinal center of said elongate implement, projection means extending radially from said handle means adjacent to and axially spaced from the distal end of said handle means, blade means secured to said handle means, said blade means including at least two spaced-apart slanted cutting edges, relative to said rotational axis, and which extend from said distal end of said implement and include the upper portions of said projection means and which describe a conical path during rotation of said implement, the lower portions of said projection means constituting a noncutting portion, each of said blade means further including a recessed groove adjoining said cutting edge and extending along the length thereof for receiving said diagnostic material collected by said edge from said situs.
 2. The structure set forth in claim 1 above, further including: a structurally weakened neck portion between said handle means and said blade means for breaking the same apart by application of manual force thereto.
 3. The structure set forth in claim 1 above, wherein: said elongate implement further includes at said dIstal end a domelike protuberance having means to scrape over said situs when said implement is removed therefrom.
 4. The structure set forth in claim 2 above wherein said elongate implement further includes a domelike protuberance and a reduced cylindrical portion fixed to said distal end, said protuberance having a peripheral edge thereon for scraping over said situs when said implement is removed therefrom.
 5. The structure set forth in claim 2 above wherein said blade means comprises at least two oppositely facing substantially parallel surfaces. 